Status:
COMPLETED
Intermittent Hypoxia and Caffeine in Infants Born Preterm
Lead Sponsor:
Children's National Research Institute
Collaborating Sponsors:
Boston University
Beth Israel Medical Center
Conditions:
Intermittent Hypoxia
Eligibility:
All Genders
32-36 years
Phase:
PHASE2
Brief Summary
Intermittent Hypoxia and Caffeine in Infants Born Preterm (ICAF) Our proposal will address the critical question: is persisting intermittent hypoxia (IH) in preterm infants associated with biochemical...
Detailed Description
Acute morbidities can contribute to adverse neurodevelopment outcomes in preterm infants born at ≤30 wks gestation, but neural damage occurring after resolution of acute morbidities may be more subtle...
Eligibility Criteria
Inclusion
- Male and female infants born preterm at ≤30 weeks + 6 days post menstrual age
- Current treatment with routine caffeine
- PMA 32 weeks + 0 days - 36 weeks + 6 days
- Anticipated last dose of routine caffeine will be by 36 weeks + 5 days
- At least 12 hours of breathing room air with no ventilatory support other than on room air nasal air flow therapy regardless of flow rate, or on room air and receiving nasal CPAP, and relapse not anticipated.
- Able to tolerate enteral medications
- It is feasible to administer the first dose of study drug no later than 36 weeks + 6 days PMA
Exclusion
- Intraventricular hemorrhage Grade III-IV or cystic periventricular leukomalacia
- Current or prior treatment for seizures
- Current or prior treatment for cardiac arrhythmias
- Known renal or hepatic dysfunction that in the opinion of the investigator would have a clinically relevant impact on caffeine metabolism
- Major malformation, inborn error of metabolism, chromosomal abnormality
- Presence of a condition for which survival to discharge unlikely
- Social, mental health, logistical or other issues that, in the opinion of the investigator, would impact the ability of the family to complete the study
Key Trial Info
Start Date :
January 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2023
Estimated Enrollment :
170 Patients enrolled
Trial Details
Trial ID
NCT03321734
Start Date
January 18 2019
End Date
June 1 2023
Last Update
September 1 2023
Active Locations (15)
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1
Loma Linda University Health System
Loma Linda, California, United States, 92354
2
Children's National Medical Center/Children's Research Institute
Washington D.C., District of Columbia, United States, 20010
3
AdventHealth Orlando
Orlando, Florida, United States, 32803
4
Johns Hopkins All Children's Hospital
St. Petersburg, Florida, United States, 33701